| (19) |
 |
|
(11) |
EP 4 360 652 A3 |
| (12) |
EUROPEAN PATENT APPLICATION |
| (88) |
Date of publication A3: |
|
26.06.2024 Bulletin 2024/26 |
| (43) |
Date of publication A2: |
|
01.05.2024 Bulletin 2024/18 |
| (22) |
Date of filing: 03.11.2017 |
|
| (51) |
International Patent Classification (IPC):
|
|
| (84) |
Designated Contracting States: |
|
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL
NO PL PT RO RS SE SI SK SM TR |
| (30) |
Priority: |
04.11.2016 US 201662417750 P
|
| (62) |
Application number of the earlier application in accordance with Art. 76 EPC: |
|
17866366.2 / 3534922 |
| (71) |
Applicant: Takeda Pharmaceutical Company Limited |
|
Osaka-shi, Osaka (JP) |
|
| (72) |
Inventors: |
|
- FIEDLER, Christian
1100 Vienna (AT)
- FRITSCHER, Eva
1090 Vienna (AT)
- HASSLACHER, Meinhard
1020 Vienna (AT)
- MITTERGRADNEGGER, Dominik
1020 Vienna (AT)
- TABISH, Tanvir
1210 Vienna (AT)
|
| (74) |
Representative: Hoffmann Eitle |
|
Patent- und Rechtsanwälte PartmbB
Arabellastraße 30
81925 München
81925 München (DE) |
|
| |
|
| (54) |
ADENO-ASSOCIATED VIRUS FORMULATIONS |
(57) Adeno-associated liquid and lyophilized pharmaceutical compositions are provided
herein. In exemplary aspects, the pharmaceutical compositions comprise about 5 mM
to about 25 mM L-histidine, about 0 mM to about 150 mM sodium chloride, about 0.001
% (w/v) to about 0.01 % (w/v) polysorbate 80 (PS80), and about 1 % to about 10% (w/v)
sucrose, trehalose, or combination thereof to AAV. In exemplary aspects, the pharmaceutical
compositions further comprise glycine or mannitol. Methods of preparing a pharmaceutical
composition comprising AAV, methods of treating a bleeding disorder in a subject,
and methods of storing AAV compositions are also provided.